MAUDE Adverse Event Report: BIOMET UK LTD. CER OPTION TYPE 1 TPR SLEVE +6; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number N/A

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign source: australia.Concomitant medical products: cer option type 1 tpr sleve +6 item#650-1068 lot#2911080.Cer opt type 1 tpr sleve 0mm item#650-1066 lot#2020020470.+6mm mod hd endo ii trial item#31-401161 lot# unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00009, 3002806535-2023-00011.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was found that taper sleeve did not match with ceramic head during hip surgery.It was reported that this was due to the +6mm trial head, and the +6mm sleeves not recreating the same construct.No consequences or impact to the patient.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Review of the photographs provided by the hospital identified that an endo trial is being used during the g7 surgery.There are specific g7 trials available for trialling and the use of the endo trials is considered as being off label.Nothing further can be gained from review of the photographs.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.The reported products were reviewed for compatibility and it was determined that the endo trial is not compatible for trialling a g7 dual mobility construct.Medical records were not provided.The root cause of the reported issue is attributed to use error - non indicated use of product.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).D10: cer option type 1 tpr sleve +6 item #650-1068 lot #2911080; cer opt type 1 tpr sleve 0mm item #650-1066 lot #2020020470; +6mm mod hd endo ii trial item #31-401161 lot #unknown; act artic e1 hip brg 28x40mm item #ep-200146 lot #65690351; cer bioloxd option hd 28mm item #650-1055 lot #3087400; cer option type 1 tpr sleve +3 item #650-1067 lot #276250; tloc 133 mp sp tp1 bm so 6.0 item #51-118060 lot #3954835; g7 osseoti 3 hole shell 50mm d item #110010243 lot #r7224675a; g7 dual mobility liner 40mm d item #110024462 lot #506770.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay corrected information.  the following sections were updated: b4, b5, g3, g6, h1, h2, h6, h10.Upon reassessment of the reported event, it was determined a medwatch report should not have been filed because item and lot number of returned products etching is not that of the reported products within the complaint.Furthermore, the item numbers etched onto the parts are not recognized as zimmer biomet product numbers.Given this information, this medwatch will be voided.

Event Description

Upon reassessment of the reported event, it was determined a medwatch report should not have been filed because item and lot number of returned products etching is not that of the reported products within the complaint.Furthermore, the item numbers etched onto the parts are not recognized as zimmer biomet product numbers.  given this information, this medwatch will be voided.

• Brand Name: CER OPTION TYPE 1 TPR SLEVE +6
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 16120213
• MDR Text Key: 308545591
• Report Number: 3002806535-2023-00010
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00887868271489
• UDI-Public: (01)00887868271489(17)310716(10)3066236
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K200959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1068
• Device Lot Number: 3066236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Patient Sex: Prefer Not To Disclose